Associate Technician (Sewing Assembly)

Aleron; Irvine (CA); Sur place; USD 30 307 - 41 328; Plein temps

Résumé du poste

Aleron is seeking an Associate Technician for sewing assembly in Irvine, CA. This contract-to-direct role focuses on manufacturing medical devices with strict GMP and regulatory requirements in a controlled cleanroom environment.

The position demands high manual dexterity, attention to detail, and teamwork. You will perform sewing assembly steps, verify work against specifications, maintain proper documentation, and support engineering investigations as needed.

Qualifications

• High school diploma or GED required.
• Minimum 1 year experience in medical assembly.
• Ability to work in a cleanroom and handle animal tissue.
• Must be able to read, comprehend, and speak English.
• Must adhere to GMP and quality standards.

Responsabilités

• Perform sewing assembly steps for transcatheter heart valve devices.
• Verify completed steps against specifications.
• Follow work instructions and record traceable data.
• Support engineering root cause analysis when nonconformance occurs.
• Maintain GMP compliance and tidy, organized work areas.
• General housekeeping and collaboration with cross functional teams.

Connaissances

Manual dexterity

Attention to detail

Cleanroom

Team collaboration

English communication

Basic computer skills

Formation

High School Diploma or GED

Outils

Needles

Scissors

Forceps

Specialized tooling

Microscope

Description du poste

Associate Technician (Sewing Assembly)

Location: Irvine, CA

Employment Type: Contract to Direct

Industry: Medical Device Assembly

Compensation: $22 - $30.40 based on experience

Schedule: Monday - Friday | 7am - 3:30pm

About the Opportunity

Manufacturing technician responsible for performing detailed sewing and tissue preparation processes used in the assembly of transcatheter heart valve devices. This role requires high manual dexterity, attention to detail, and adherence to strict regulatory, quality, and contamination control procedures within a controlled cleanroom manufacturing environment.

Why You'll Love Working Here

• Supportive, team-driven culture that values collaboration, transparency, and accountability
• Opportunity to grow your career with a global workforce solutions leader serving multiple industries
• People-first environment that encourages employees to bring their authentic selves to work
• Strong focus on partnership, innovation, and delivering meaningful results for clients and candidates

What You'll Do

Use tools - needles, scissors, forceps, specialized tooling, microscope - to perform assigned steps, in rotation, in the sewing assembly of valves.

• Perform verifications, against specifications, of completed steps, and execute work in the assembly line.
• Review, follow, and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records.
• Support activities correspond to other work procedures, as requested, to provide support to operations processes.
• Assist Engineering in root cause analysis investigation for component nonconformance.
• Maintain compliance with company Quality Management System requirements, including applicable Good Manufacturing Practices (GMP) and regulatory standards.
• Maintain reliable and consistent attendance to support production operations, including punctual arrival and the ability to work full scheduled shifts and overtime as required to meet operational and production needs.
• Other incidental duties: General work area housekeeping.

What Sets You Apart

• Ability to use small hand tools, steady hand-eye coordination, and high manual dexterity/fine motor skills.
• Must have ability to perform detailed tasks accurately.
• Must be able to work in a cleanroom environment.
• Must be able to handle animal tissue and wet processes.
• Must be able to work effectively and collaborate within cross functional teams.
• Ability to read, comprehend and speak English, and good communication skills required.
• Knowledge of and adherence to Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.
• Successful completion of required training and demonstrated competency on assigned manufacturing processes.
• Adhere to all rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
• Basic computer skills.

What You'll Bring

• High School Diploma or GED
• Minimum 1 year experience performing medical assembly

Candidates without a diploma may demonstrate equivalent competency through a validated external assessment designed to evaluate comprehension, language, and related abilities at a high school level.

Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct) are an Equal Opportunity Employer. Race/Color/Gender/Religion/National Origin/Disability/Veteran.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.